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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K132316
Device Name MULTIVIEW
Applicant
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Applicant Contact EILEEN M BOYLE
Correspondent
Hologic, Inc.
35 Crosby Dr.
Bedford,  MA  01730
Correspondent Contact EILEEN M BOYLE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/25/2013
Decision Date 10/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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